Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea

August 26, 2019 updated by: Aclaris Therapeutics, Inc.

Multicenter, Open-Label, Interventional Study on the Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Subjects With Rosacea

This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • SkinCare Physicians
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Skin Laser and Surgery Specialists of NY/NJ
    • New York
      • New York, New York, United States, 10016
        • Laser & Skin Surgery Center of New York Professional Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Documented clinical diagnosis of rosacea.

Exclusion Criteria:

  • History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease
  • Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne
  • Current treatment with monoamine oxidase (MAO) inhibitors
  • Current treatment with niacin ≥ 500 mg/day
  • Greater than 3 inflammatory lesions on the face
  • History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxymetazoline + Energy-Based Therapy
Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.
Drug: Oxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application
Other Names:
  • Rhofade
Device: Energy-Based Therapy
Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: Baseline (Day 1) to Day 56
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.
Baseline (Day 1) to Day 56
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point
Time Frame: Baseline (Day 1) to Day 56
The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.
Baseline (Day 1) to Day 56
Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point
Time Frame: Baseline (Day 1) to Day 56
The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.
Baseline (Day 1) to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aclaris Therapeutics, Inc.

Investigators

  • Study Director: Nancy Alvandi, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO-MA-MED-0530

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rosacea

Clinical Trials on Oxymetazoline HCL 1.0% Cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe